Court Rules for Makers of Ortho Evra Contraceptive

Federal law preempts the design defect claims of a woman who suffered a stroke while using the Johnson & Johnson Ortho Evra birth control patch, the U.S. Court of Appeals for the Sixth Circuit held Dec. 11 (Yates v. Ortho-McNeil-Janssen Pharm., Inc., 2015 BL 406634, 6th Cir., 15-3104, 12/11/15).

The court first rejected Stephanie Yates’s claim that, after Food and Drug Administration approval, the manufacturer could have reduced the amount of estrogen in the patch from “0.75 mg/patch to 0.6 mg/patch.”

Changing “the dosage level of the active ingredient” wouldn’t be a “minimal” change and would require ...